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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceKAPPA 600/700/800/900 & ENPULSE FAMILIES OF PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP980035
Supplement NumberS061
Date Received08/21/2006
Decision Date09/19/2006
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at trivirix minneapolis, inc. , milaca, minnesota for the final testing, activating, labeling and packaging of the model 2490h carelink monitor and the model 2020a cardiosight reader.
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